De Novo DEN180012

Device
LOADPRO™ Intraoperative Rod Strain Sensor
Contact
richard r. navarro
De Novo number
DEN180012
Product code
QFP
Regulation
888.3090
Classification name
intraoperative orthopedic strain sensor
Decision
granted (DENG)
Decision date
2019-03-28
Date received
2018-03-14
Classification advisory
Orthopedic
Review advisory
Orthopedic
Type
Direct

Current FDA Classification#

Product code
QFP
Device name
Intraoperative Orthopedic Strain Sensor
Medical specialty
Orthopedic
Device class
2
Regulation
888.3090
Implant
N
Life sustain/support
N